FDA 510(k) Applications for Medical Device Product Code "DRN"
(Device, Counter-Pulsating, External)

FDA 510(k) Number Applicant Device Name Decision Date
K042413 APPLIED CARDIAC SYSTEMS ACS MODEL NCP-2 12/09/2004
K792430 CARDIASSIST CORP. CARDIASSIST EXTERNAL COUNTERPULSATION 01/23/1980
K050172 CARDIOMEDICS, INC. CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 03/31/2005
K022107 CARDIOMEDICS, INC. CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 08/08/2002
K023427 CARDIOMEDICS, INC. CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 01/07/2003
K010261 CARDIOMEDICS, INC. CARDIOMEDICS ECP SYSTEM 02/28/2001
K872034 CARDIOMEDICS, INC. CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM 09/18/1987
K130439 CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING 12/12/2013
K792354 CIRCULATOR BOOT CORP. "THE CIRCULATOR BOOT" 01/09/1980
K082134 CIRCULATOR BOOT CORP. CIRCULATOR BOOT 05/07/2009
K833627 CIRCULATOR BOOT CORP. CIRCULATOR MINIBOOT 05/23/1984
K971026 CIRCULATOR BOOT CORP. THE CIRCULATOR BOOT 08/14/1997
K030532 CPCA2000 INC CPCA2000 COUNTERPULSATION SYSTEM 03/14/2003
K052611 ECP HEALTH INC. ECP HEALTH SYSTEM, MODEL 2005 04/26/2006
K021340 EXTERNAL COUNTERPULSATION LAB AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE 01/30/2003
K012141 EXTERNAL COUNTERPULSATION LAB AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE 10/25/2001
K023701 LIVING DATA TECHNOLOGIES CORPORATION ANGIONEW-IV 01/30/2003
K033657 LIVING DATA TECHNOLOGIES CORPORATION MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V 12/19/2003
K980937 NICORE EQUIPMENT & LEASING, INC. NICORE MODEL ESP -1 09/15/2000
K023016 NICORE EQUIPMENT & LEASING, INC. NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE 12/04/2002
K030587 S-TCT HEALTH INC. EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP 05/30/2003
K081359 SCOTTCARE CORPORATION GENESIS ECP 05/29/2008
K022078 SOLA MEDICAL DEVICES, LLC SOLA, COUNTER-PULSATION, MODEL SECP-S 01/10/2003
K152115 Stage 2 Innovations Renew NCP-5 External Counterpulsation System 12/17/2015
K882401 STONY BROOK TRADING AND DEVELOPMENT CORP. STONY BROOK MODEL EECP-MC1 03/03/1989
K940264 VASOGENICS, INC. VASOGENICS EECP-MC2 02/23/1995
K020857 VASOMEDICAL, INC. EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER 06/14/2002
K033617 VASOMEDICAL, INC. EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY 03/01/2004
K003469 VASOMEDICAL, INC. EECP THERAPY SYSTEM, MODEL TS3 12/06/2000
K173483 Xtreem Pulse, LLC Pure Flow External Counter-Pulsation Device 05/30/2018


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